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Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
This study has been completed.
Sponsor:
Chugai Pharmaceutical
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144573
First received: September 2, 2005
Last updated: December 11, 2008
Last verified: December 2008
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Purpose
This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.
| Condition | Intervention |
|---|---|
| Rheumatoid Arthritis | Drug: MRA(Tocilizumab) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment |
Resource links provided by NLM:
Further study details as provided by Chugai Pharmaceutical:
Primary Outcome Measures:
- 20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: throughout study ]
Secondary Outcome Measures:
- Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [ Time Frame: Week 0, Week 4 ]
| Enrollment: | 14 |
| Study Start Date: | January 2005 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria
- Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria
- Patients with RA at least 6 months prior to enrollment
- Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min
Exclusion criteria
- Patients with Class IV Steinbrocker functional impairment at enrollment
- Patients who are undergoing dialysis
- Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144573
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144573
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
| Study Director: | Takahiro Kakehi | Chugai Pharmaceutical |
More Information
| Responsible Party: | Chugai Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00144573 History of Changes |
| Other Study ID Numbers: |
MRA221JP |
| Study First Received: | September 2, 2005 |
| Last Updated: | December 11, 2008 |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Renal Insufficiency Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 26, 2017